VIDAS Varicel Zoster IGG 60T Recalled Due to Storage Condition Excursion
Biomerieux Inc is recalling VIDAS Varicel Zoster IGG 60T (Catalog 30217, Batch 229478) due to storage temperature and time exceedance. The recalled units cannot be guaranteed to perform accurately.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a diagnostic device with exceeded storage conditions affecting product performance. No illnesses or injuries have been reported. The recall presents a risk of unreliable test results that could lead to misdiagnosis, meeting the High threshold for risk-of-harm products without reported injury.
Plain-English summary
Biomerieux Inc is recalling the VIDAS Varicel Zoster IGG 60T (Catalog 30217, Batch 229478), a diagnostic test kit. The recall was initiated because the product experienced temperature and time storage conditions that exceeded specifications during distribution.
When storage conditions are exceeded beyond product specifications, the performance of the diagnostic device cannot be guaranteed. This means test results from affected units may not be reliable.
The affected batch was distributed nationwide in the United States. Consumers or healthcare facilities in possession of units from Batch 229478 should discontinue use and contact Biomerieux Inc for instructions regarding replacement or proper handling of affected units.
The recalled product
- Product
- VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217
- Manufacturer
- Biomerieux Inc
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 03573026064518
- Batch Numbers: 229478
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 94 recalled by Biomerieux Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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